Practice Patterns in Distinguishing Between Background Pain and Breakthrough Pain During Patient Education: a Korean Physician Survey.

This study sought to explore the association between physician practice patterns and patient education, with a focus on breakthrough cancer pain (BTcP). A nationwide online survey was conducted by 92 Korean physicians. Thirteen questions on Korean physician's assessment, prescription, patient education practices, and knowledge regarding BTcP were administered. Based on their responses, physicians were divided using two methods: (1) by their patient education practices, where the "education group" always explained the distinction between background pain and BTcP and the "less education group" which explained it less frequently; and (2) by their definition of BTcP, as occurring "after control of background pain" or "regardless of background pain." We compared practice patterns using Fisher's exact test or Student's t test and performed multiple logistic regression analysis. The "education group" (65 physicians, 70.7 %) was more likely than the "less education group" to assess BTcP meticulously (odds ratio [OR] 17.13, 95 % confidence interval [CI] 4.98-58.94), prepare rescue medications in advance (OR 3.67, 95 % CI 1.36-9.90), and give explicit instructions regarding medications (OR 36.68, 95 % CI 5.63-239.15). Physicians who defined BTcP as occurring "after control of background pain" were more likely to explain how to take rescue medication (P < 0.05) than physicians who defined BTcP as occurring "regardless of background pain." Korean physicians' BTcP practice patterns may be affected by whether they consistently educate patients on the distinction between background pain and BTcP, regardless of their knowledge of the definition of BTcP.

Multicenter, cross-sectional observational study of the impact of neuropathic pain on quality of life in cancer patients.

PURPOSE: Neuropathic cancer pain (NCP) is a common and potentially debilitating symptom in cancer patients. We investigated the prevalence of NCP, as well as its management and association with QOL. METHODS: Cancer patients with pain ≥1 on the visual analogue scale (VAS) were surveyed with the Douleur Neuropathique (DN4) questionnaire, the Brief Pain Inventory-Short Form (BPI-SF), and the EuroQOL five dimensions (EQ-5D) questionnaire. The associations between NCP and pain severity or NCP and QOL, while controlling for variables relevant to QOL, were then analyzed. RESULTS: A total of 2003 patients were enrolled in this survey; the prevalence of NCP was 36.0% (n = 722, 95% CI, 32.5-39.5). We found that NCP in cancer patients was closely correlated to a higher pain severity (BPI-SF; 4.96 ± 1.94 versus 4.24 ± 2.02, p < 0.001), and in patients with NCP, pain more severely interfered with daily living, as compared to those without NCP (BPI-SF; 4.86 ± 2.71 versus 4.41 ± 2.87, p < 0.001). Patients with NCP also had worse QOL than those without NCP, as measured by EQ-5D index score (0.47 ± 0.30 vs. 0.51 ± 0.30, p = 0.005), and this was confirmed using multivariate analysis (p < 0.001), even after controlling for other variables such as age, sex, disease stage, cancer duration, radiotherapy, chemotherapy, and comorbidities. Importantly, adjuvant analgesics were used in less than half of patients with NCP (n = 358, 46.4%). CONCLUSIONS: We found that NCP in cancer patients was significantly associated with a worsened QOL, and current management is inadequate. Therefore, future research aimed at developing improved strategies for management of NCP is required.

Home-based supportive care in advanced cancer: systematic review.

OBJECTIVES: This study systematically reviewed the literature on the effect of home-based supportive care (HbSC) programmes on the quality of life (QoL) of patients with advanced cancer. METHODS: The research question 'Do home-based supportive care programmes for patients with advanced cancer improve their QoL?' was addressed. After registering the plan with PROSPERO (CRD42022341237), literature published from 1 January 1990 to 30 May 2023 was searched on PubMed, Embase, Cochrane database, CINAHL and Web of Science, and reviewed for inclusion based on predefined criteria. This review only included trial studies published in English. RESULTS: Of 5,276 articles identified, 17 studies were judged suitable for inclusion in this review. The components of HbSC programmes included home visits, patient and caregiver education, home nursing, psychotherapy, exercise, telephone consultation, and multidisciplinary team meetings. Nine studies reported improvements in QoL, including social functioning, emotional functioning, and subjective QoL. CONCLUSION: HbSC programmes appear to enable the improvement of the QoL of patients with advanced cancer. The area of QoL that shows improvement could vary depending on the HbSC components. More studies that address HbSC programmes are needed to select patients at the proper time and provide suitable programmes for patients to benefit most.

SupporTive Care At Home Research (STAHR) for patients with advanced cancer: Protocol for a cluster non-randomized controlled trial.

Advancements in the treatment and management of patients with cancer have extended their survival period. To honor such patients' desire to live in their own homes, home-based supportive care programs have become an important medical practice. This study aims to investigate the effects of a multidimensional and integrated home-based supportive care program on patients with advanced cancer. SupporTive Care At Home Research is a cluster non-randomized controlled trial for patients with advanced cancer. This study tests the effects of the home-based supportive care program we developed versus standard oncology care. The home-based supportive care program is based on a specialized home-based medical team approach that includes (1) initial assessment and education for patients and their family caregivers, (2) home visits by nurses, (3) biweekly regular check-ups/evaluation and management, (4) telephone communication via a daytime access line, and (5) monthly multidisciplinary team meetings. The primary outcome measure is unplanned hospitalization within 6 months following enrollment. Healthcare service use; quality of life; pain and symptom control; emotional status; satisfaction with services; end-of-life care; advance planning; family caregivers' quality of life, care burden, and preparedness for caregiving; and medical expenses will be surveyed. We plan to recruit a total of 396 patients with advanced cancer from six institutions. Patients recruited from three institutions will constitute the intervention group, whereas those recruited from the other three institutions will comprise the control group.

Impact of multidrug resistance on outcomes in hematologic cancer patients with bacterial bloodstream infections.

Despite the improved outcomes in patients with hematological malignancies, infections caused by multidrug-resistant organisms (MDROs) pose a new threat to these patients. We retrospectively reviewed the patients with hematological cancer and bacterial bloodstream infections (BSIs) at a tertiary hospital between 2003 and 2022 to assess the impact of MDROs on outcomes. Among 328 BSIs, 81 (24.7%) were caused by MDROs. MDRO rates increased from 10.3% (2003-2007) to 39.7% (2018-2022) (P < 0.001). The 30-day mortality rate was 25.0%, which was significantly higher in MDRO-infected patients than in non-MDRO-infected patients (48.1 vs. 17.4%; P < 0.001). The observed trend was more pronounced in patients with newly diagnosed diseases and relapsed/refractory disease but less prominent in patients in complete remission. Among MDROs, carbapenem-resistant Gram-negative bacteria exhibited the highest mortality, followed by vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus, and extended-spectrum ß-lactamase-producing Enterobacteriaceae. Multivariate analysis identified independent risk factors for 30-day mortality as age ≥ 65 years, newly diagnosed disease, relapsed/refractory disease, MDROs, polymicrobial infection, CRP ≥ 20 mg/L, and inappropriate initial antibiotic therapy. In conclusion, MDROs contribute to adverse outcomes in patients with hematological cancer and bacterial BSIs, with effects varying based on the underlying disease status and causative pathogens. Appropriate initial antibiotic therapy may improve patient outcomes.

A nationwide real-world study for evaluation of effectiveness and safety of T-DM1 in patients with HER2-positive metastatic breast cancer in Korea (KCSG BR19-15).

Purpose: This study aimed to investigate clinical practices and factors related to the outcomes of T-DM1 use in patients with HER2-positive metastatic breast cancer (mBC). Methods: We included patients with HER2-positive mBC who received T-DM1 as a palliative therapy between August 2017 and December 2018. The safety and outcomes of T-DM1, including overall response rate (ORR), progression-free survival (PFS), and overall survival (OS), were evaluated. A Cox proportional hazards model was used to estimate the hazard ratio and 95% confidence interval (CI) for mortality or progression to HER2-positive mBC. Results: In total, 824 patients were enrolled during the study period. The mean age of patients was 58 years, and 516 (62.6%) patients relapsed after curative treatment. Excluding a history of endocrine therapy, 341 (41.4%) patients previously received none or first-line chemotherapy, 179 (21.7%) received second-line therapy, and 303 (36.9%) received third-or later-line chemotherapy before T-DM1 therapy. During a median follow-up of 16.8 months, the ORR was 35%, the median PFS was 6.6 months, and the median OS was not reached. The clinical factors associated with the hazard of progression were age (<65 years), poor performance status (⩾2), advanced line of palliative chemotherapy (⩾2), prior pertuzumab use, and treatment duration of palliative trastuzumab (<10 months). Common grade 3-4 adverse events were thrombocytopenia (n = 107, 13.2%), neutropenia (n = 23, 2.8%), anemia (n = 21, 2.6%), and elevated liver enzyme (n = 20, 2.5%). Hypokalemia (⩽3.0 mmol/L) and any-grade bleeding events occurred in 25 (3.1%) and 94 (22.6%) patients, respectively. Conclusion: This is the first nationwide real-world study of T-DM1 use in patients with HER2-positive mBC in Korea. The effectiveness and toxicity profiles of T-DM1 in real-world practice were comparable to those in randomized trials. Moreover, patient factors and previous anti-HER2 therapy could predict the outcomes of T-DM1 therapy.

Noninterventional observational study using high-dose controlled-release oxycodone (CR oxycodone) for cancer pain management in outpatient clinics.

PURPOSE: Efficacy, safety, and quality of life (QoL) for patients receiving larger doses of controlled-release oxycodone (CR oxycodone) in outpatient clinics are evaluated. METHODS: The use of high-dose CR oxycodone and adjuvant drugs for pain management, pain intensity, parameters associated with quality of life, and adverse effects in cancer patients treated with high-dose CR oxycodone (≥80 mg/day) was prospectively observed for 8 weeks. Data from 486 cancer patients receiving high-dose CR oxycodone were collected from 44 hospitals during the period from February 2009 to March 2010. RESULTS: Three hundred eighteen of the total 486 patients treated with high-dose CR oxycodone were followed up for 8 weeks. Pain intensity significantly improved from a mean numeric rating scale (NRS) 5.49 to NRS 4.33 (P < 0.0001). Dosage of CR oxycodone increased from a mean of 130.0 to a mean of 174.9 (P < 0.0001). QoL including activity, walking, and sleeping significantly improved after 8 weeks. At baseline, 138 complained of adverse effects, of which constipation (30.2%) was the most common followed by dry mouth (8.8%) and dizziness (8.2%). After 8 weeks, 128 patients complained of adverse effects such as constipation (27.0%), nausea (5.7%), dry mouth (5.7%), and dizziness (5.0%). After 8 weeks of high-dose CR oxycodone, adverse effects did not increase. CONCLUSION: This study suggests that over an 8-week period, the use of high-dose CR oxycodone for cancer pain management is efficient, safe, and tolerable in outpatient clinics.

Awareness of incurable cancer status and health-related quality of life among advanced cancer patients: a prospective cohort study.

BACKGROUND: Many patients near death report an interest in knowing their prognoses. Patients' awareness of disease status may lead to more appropriate care and maintained or improved quality of life. However, it is not known whether advanced cancer patients' awareness of disease status is associated with patients' quality of life. AIM: We aimed to examine the effect of patients' awareness of disease status on the health-related quality of life (HRQOL) among advanced cancer patients undergoing palliative chemotherapy. DESIGN: In this prospective cohort study, patients were followed-up at 4-6 weeks and 2-3 months after the initial palliative chemotherapy. Patients' awareness of disease status, and demographic and clinical characteristics were assessed at baseline, and depression and anxiety using the Hospital Anxiety and Depression Scale (HADS) and HRQOL using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) were assessed three times. SETTING / PARTICIPANTS: In total, 100 patients with advanced cancer starting palliative chemotherapy were recruited from two tertiary university hospitals and from the Korea National Cancer Center. RESULTS: Patients with advanced cancer undergoing palliative chemotherapy experienced deteriorated HRQOL. Of these, the patients who were aware of their disease status as incurable had significantly higher role (p=0.002), emotional (p=0.025), and social functioning (p=0.002), and lower fatigue (p=0.008), appetite loss (p=0.039), constipation (p=0.032), financial difficulties (p=0.019), and anxiety (p=0.041) compared with patients unaware of disease status. CONCLUSION: Our findings demonstrate the importance of patients' awareness of disease status to HRQOL.

Lambert-Eaton myasthenic syndrome (LEMS) in a patient with lung cancer under treatment with pembrolizumab: a case study.

Pembrolizumab is an immune checkpoint inhibitor (ICI) against the programmed death-1 receptor. Herein, we introduce a rare adverse effect during using pembrolizumab. We present the case of an 80-year-old man with biopsy-proven unresectable double primary squamous cell carcinoma and large cell neuroendocrine carcinoma of the lung. After using pembrolizumab for 10 months, he complained of muscle weakness of both upper and lower extremities. In a nerve conduction study, the repetitive nerve stimulation test in the abductor digiti minimi was diagnostic of Lambert-Eaton myasthenic syndrome (LEMS): low in the amplitude of compound muscle action potential (1.4 mV), 28.6% decrement in the 5-Hz stimulation, and 579% increment in the 50-Hz stimulation. The disease did not progress after the discontinuation of pembrolizumab, even without any anti-cancer treatment for 12 months. We believe our clinical experience of this rare and unexpected adverse effect should be shared.

Impacts of Subtype on Clinical Feature and Outcome of Male Breast Cancer: Multicenter Study in Korea (KCSG BR16-09).

PURPOSE: The treatment of male breast cancer (MBC) has been extrapolated from female breast cancer (FBC) because of its rarity despite their different clinicopathologic characteristics. We aimed to investigate the distribution of intrinsic subtypes based on immunohistochemistry, their clinical impact, and treatment pattern in clinical practice through a multicenter study in Korea. MATERIALS AND METHODS: We retrospectively analyzed clinical data of 248 MBC patients from 18 institutions across the country from January 1995 to July 2016. RESULTS: The median age of MBC patients was 63 years (range, 25 to 102 years). Among 148 intrinsic subtype classified patients, 61 (41.2%), 44 (29.7%), 29 (19.5%), and 14 (9.5%) were luminal A, luminal B, human epidermal growth factor receptor 2, and triple-negative breast cancer, respectively. Luminal A subtype showed trends for superior survival compared to other subtypes. Most hormone receptor-positive patients (166 patients, 82.6%) received adjuvant endocrine treatment. Five-year completion of adjuvant endocrine treatment was associated with superior disease-free survival (DFS) in patients classified with an intrinsic subtype (hazard ratio [HR], 0.15; 95% confidence interval [CI], 0.04 to 0.49; p=0.002) and in all patients (HR, 0.16; 95% CI, 0.05 to 0.54; p=0.003). CONCLUSION: Distribution of subtypes of MBC was similar to FBC and luminal type A was most common. Overall survival tended to be improved for luminal A subtype, although there was no statistical significance. Completion of adjuvant endocrine treatment was associated with prolonged DFS in intrinsic subtype classified patients. MBC patients tended to receive less treatment. MBC patients should receive standard treatment according to guidelines as FBC patients.

Second-line chemotherapy for advanced gastric cancer in Korea.

Stomach cancer is still one of the most prevalent malignancies and is the main cause of cancer deaths worldwide. The outcome for patients with metastasis, as well as for those with tumor recurrence, is dismal, with median survival time not greater than a year. Patients with unresectable locally advanced or metastatic lesions have been treated with systemic chemotherapy, and several randomized studies have demonstrated the benefit of chemotherapy compared with best supportive care. Recently, randomized phase III trials have presented a benefit of second-line chemotherapy compared with supportive care alone. However, it is not known at present which drug is the most effective in this setting. In Korea, the practice of offering second-line treatment to patients with advanced gastric cancer (AGC) is common, and many prospective clinical trials investigating clinical outcomes of second-line chemotherapy have been reported. Therefore, to define the potential role of second-line chemotherapy and to help to select an effective regimen, we review the published Korean prospective data concerning the use of chemotherapy in the second-line setting for the treatment of AGC. No phase III trials but 20 phase II trials were identified. The benefit of second-line chemotherapy in AGC has indirect evidence considering prolongation of progression-free survival (PFS) and improvement of the response rate. Taxanes, irinotecan, and oxaliplatin have been studied much and might be promising drugs considering cross-resistance to a 5-fluorouracil and cisplatin combination (FP). A large, prospective, multicenter, randomized phase III study is warranted to select the most effective second-line chemotherapeutic agents.

Health economics of a palliative care unit for terminal cancer patients: a retrospective cohort study.

PURPOSE: The objective of this study was to evaluate cost-reduction efficacy of a palliative care unit (PCU) by analyzing medical expenses of terminal cancer patients. METHODS: Hospital bills and medical records of 656 patients who died of cancer from January to December 2007 at one university hospital in Seoul were analyzed. RESULTS: Of the total 656 patients, 126 died in the PCU. Compared to non-PCU patients, PCU patients were more likely to permit do-not-resuscitate (DNR), visit the emergency room (ER), and receive palliative chemotherapy (P < 0.001, P = 0.045, P = 0.002). The non-PCU patients were admitted to the intensive care unit (ICU), used a ventilator, and received hemodialysis more often (P < 0.001, P < 0.001, P < 0.001). Total medical cost per all patients within 6 months of death averaged $27,863. There was a significant difference in medical costs starting at 2 months before death between PCU and non-PCU patients. The medical cost of the PCU group was 32.8% lower 1 month before death and 33.0% lower 2 months before death than the non-PCU group (P < 0.001, P < 0.001). Patients using PCU services, those with solid cancers, and those with less than a high school education paid lower medical expenses (P < 0.05) CONCLUSION: Cost savings of the PCU were verified. It was also determined that specific factors were tied to increased medical expenses during the last 6 months of life. If these parameters are controlled properly, additional cost savings, associated with palliative care could be realized.

Effect of advanced cancer patients' awareness of disease status on treatment decisional conflicts and satisfaction during palliative chemotherapy: a Korean prospective cohort study.

PURPOSE: Our purpose was to evaluate the effect of cancer patients' awareness of their incurable disease status on decisional conflict and satisfaction with treatment choice. METHODS: In this prospective cohort study, advanced cancer patients who were offered palliative chemotherapy completed questionnaires on their knowledge of their condition, their treatment decision conflicts, and their satisfaction with their treatment decisions. RESULTS: We enrolled 98 patients; 94 reported that they were aware of their advanced status and 50 were not. Decisional conflicts for all patients showed a significant decrease after treatment, but aware patients were significantly more satisfied with their decision (P = 0.02). CONCLUSION: Patients' awareness of their incurable status was associated with greater satisfaction with their decision to receive palliative chemotherapy.

Pulmonary Metastasizing Low-Grade Endometrial Stromal Sarcoma: Case Report and Review of Diagnostic Pitfalls.

Pulmonary manifestations of benign metastasizing leiomyoma (BML) usually include multiple well-defined, round, bilateral nodules. Low-grade endometrial stromal sarcoma (LG-ESS) is a rare uterine tumor. A 70-year-old woman visited the clinic complaining of acute cough and dyspnea in April 2017. Chest computed tomography (CT) revealed pneumothorax and multiple pulmonary nodules. She had a history of hysterectomy for uterine leiomyoma 23 years ago. Biopsy revealed that the pulmonary masses were consistent with BML. However, the patient had two subsequent episodes of acute, recurrent respiratory distress, accompanied by massive pleural effusions and hydropneumothorax over the next two years. A chest CT performed for acute dyspnea revealed large and multiple hydropneumothoraces. The size and distribution of pulmonary masses were aggravated along with cystic changes and bilateral pleural effusions. Given this aggressive feature, additional immunohistochemical findings and gynecologic pathologist review confirmed the correct diagnosis to be LG-ESS. After initiating anti-estrogen therapy, the patient achieved a partial response, without recurrence of symptoms, for 28 months. Metastatic LG-ESS responds well to anti-hormonal therapy. If the clinical pattern of a disease is different than expected, the possibility of a correction in the diagnosis should be considered.

Effect of Acupuncture on Delayed Emesis for the Patients Who Received High-Emetogenic Chemotherapy with Standard Antiemetic Prophylaxis (KHMC-HO-01): An Open-Label, Randomized Study.

Background: Chemotherapy-induced nausea and vomiting (CINV) is one of the most important issues associated with chemotherapy. The additional or synergistic effect of acupuncture on CINV remains controversial. Methods: Patients were randomized into either the group that received standard antiemetics with acupuncture (Arm A) or standard antiemetics only (Arm C). Acupuncture with manual stimulation was applied at eight predefined points and was started before the first cycle of chemotherapy on the first day and two additional sessions were administered on the second day of chemotherapy. Acute and delayed CINV was assessed using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR) and the MASCC Antiemesis Tool (MAT). The primary outcome was the delayed nausea score assessed using the RINVR. Results: Overall, 42 patients were included. In the delay phase, the severity of delayed nausea was slightly lower without significance in Arm A than in Arm C (5.35 vs. 5.98, p = 0.3011). Similarly, patients in Arm A reported less severe vomiting than those in Arm C (0.75 vs. 1.25, p = 0.3064). Delayed nausea and vomiting assessed by the MAT showed significant relief with acupuncture compared to standard antiemesis alone. In terms of acute emesis, there was no significant difference between the two arms according to either scoring method. Conclusions: Delayed nausea after HEC tended to decrease with acupuncture using the RINVR score, though it was also not significant. With the MAT assessment, delayed emesis (nausea and vomiting) was significantly improved with acupuncture, suggesting a promising effect of acupuncture. This trial is registered with KCT0006477.

Association between Timing and Duration of Adjuvant Chemotherapy and Colorectal Cancer Survival in Korea, 2011-2014: A Nationwide Study based on the Health Insurance Review and Assessment Service Database.

Background: Population-based analyses of the treatment outcomes of colorectal cancer (CRC) in Asian countries are limited. Therefore, we conducted a nationwide study to assess the relationship between the timing and duration of adjuvant chemotherapy (AC) and survival in patients with CRC in South Korea. Methods: Data on AC from the Health Insurance Review and Assessment Service Database (HIRA) were analyzed, and the survival of patients who underwent curative-intent surgical resection for CRC between 2011 and 2014 was investigated. Results: From the HIRA data, 45,992 patients with stage II-III CRC were identified. Chemotherapy regimens were administered as follows: 10,640 (23.3%) received 5-fluorouracil and leucovorin/capecitabine (FL/CAP), 13,083 (28.7%) received FL/CAP plus oxaliplatin (FOLFOX/CAPOX), 299 (0.7%) received uracil and tegafur/doxifluridine (UFT/D), and 21,570 (47.3%) underwent surgery alone. Patients who did not receive AC had worse survival than those who received AC in both the colon and rectum groups (HR, 1.96, 95% CI, 1.85-2.07 and HR, 2.18, 95% CI, 2.01-2.37, respectively). Regarding patients with stage II-III CRC, AC initiation ≥ 2 months after surgery was associated with a significant decrease in overall survival (OS) (FL/CAP: HR, 1.82; 95% CI, 1.53-2.17 and FOLFOX/CAPOX: HR, 2.92; 95% CI, 2.47-3.45); however, the effects of UFT/D regimens were not statistically significant. For patients with stage II-III colon cancer, AC <3 months had lower OS (FL/CAP: HR, 3.72, 95% CI, 2.80-4.94; FOLFOX/CAPOX: HR, 2.15, 95% CI, 1.87-2.47; and UFT/D: HR, 1.74, 95% CI, 0.56-5.41). In terms of patients with stage II-III rectal cancer, AC <3 months, regardless of chemotherapy regimens, had a significant lower survival (FL/CAP: HR, 1.91, 95% CI, 1.66-2.20; FOLFOX/CAPOX: HR, 2.20, 95% CI, 1.75-2.77; and UFT/D: HR, 3.71, 95% CI, 1.45-9.44). Conclusions: Postoperative time to initiation and duration of AC were associated with survival. Based on our results, initiating AC within 2 months after surgery and administering AC for >3 months can potentially have an OS benefit in patients with stage II-III CRC.

Data collection framework for electronic medical record-based real-world data to evaluate the effectiveness and safety of cancer drugs: a nationwide real-world study of the Korean Cancer Study Group.

Background: Electronic medical records (EMRs) have the highest value among real-world data (RWD). The aim of the present study was to propose a data collection framework of EMR-based RWD to evaluate the effectiveness and safety of cancer drugs by conducting a nationwide real-world study based on the Korean Cancer Study Group. Methods: We considered all patients who received ramucirumab plus paclitaxel (RAM/PTX) for gastric cancer and trastuzumab emtansine (T-DM1) for breast cancer at relevant institutions in South Korea. Standard operating procedures for systematic data collection were prospectively developed. Investigator reliability was evaluated using the concordance rate between the recommended input value for representative fictional cases and the input value of each investigator. Reliability of collected data was evaluated twice during the study period at three institutions randomly selected using the concordance rate between the previously collected data and data collected by an independent investigator. The reliability results of the investigators and collected data were used for revision of the electronic data capture system and site training. Results: Between the starting date of medical insurance coverage and December 2018, a total of 1063 patients at 56 institutions in the RAM/PTX cohort and 824 patients at 60 institutions in the T-DM1 cohort were included. Mean investigator reliability in the RAM/PTX and T-DM1 cohorts was 73.5% and 71.9%, respectively. Mean reliability of collected data in the RAM/PTX and T-DM1 cohort was 90.0% for both cohorts in the first analysis and 89.0% and 84.0% in the second analysis, respectively. Mean missing values of the RAM/PTX and T-DM1 cohorts at the time of simulation of fictional cases and final data analysis decreased from 20.7% to 0.46% and from 18.5% to 0.76%, respectively. Conclusion: This real-world study provides a framework that ensures relevance and reliability of EMR-based RWD for evaluating the effectiveness and safety of cancer drugs.

Clinicopathologic characteristics and treatment outcomes of hepatoid adenocarcinoma of the stomach, a rare but unique subtype of gastric cancer.

BACKGROUND: Gastric hepatoid adenocarcinoma (HAC) is a special type of gastric cancer that morphologically mimics hepatocellular carcinoma. In this study, we performed an evaluation of clinicopathologic characteristics, treatment outcome, and prognosis in patients with gastric HAC. METHODS: We consecutively enrolled patients with pathologically proven gastric HAC at Seoul National University Hospital between January 1996 and December 2008 and conducted a retrospective review. Among 15,253 patients with gastric cancer, 26 patients (0.17%) were diagnosed as gastric HAC. RESULTS: Among 26 patients, 22 were male and the median age was 63. Stage at diagnosis was stage IB in 3 patients, stage II in 6 patients, stage III in 7 patients, and stage IV in 10 patients. Eight patients out of 18 patients with stage IB, II, III, and IV relapsed after curative surgery. Relapse-free survival for these patients was 16.67 months. The most common metastatic site was intraabdominal lymph nodes (n = 9), followed by the liver (n = 8). Thirteen patients received palliative chemotherapy. The most commonly used regimen was a combination of fluoropyrimidine and platinum. Partial response was observed in one patient and stable disease in 5 patients. Median overall survival and progression free survival of these patients were 8.03 (95% CI: 6.59-9.47) and 3.47 months (95% CI: 0.65-6.29), respectively. CONCLUSIONS: Gastric HAC is a very rare but unique type of stomach cancer. Early detection of this type of cancer is of critical importance to patient prognosis. Additional studies to reveal the biology of this tumor are warranted.

Survival benefit of gastrectomy ± metastasectomy in patients with metastatic gastric cancer receiving chemotherapy.

BACKGROUND: This study was performed to investigate the role of surgery in patients with gastric cancer and distant metastases who had received systemic chemotherapy. METHODS: Patients with newly diagnosed gastric cancer and synchronous distant metastases who had received chemotherapy (n = 274) were categorized into 3 groups according to the surgical treatment rendered: complete gross resection of both primary and metastatic sites (group A; n = 42); debulking gastrectomy (group B; n = 47); and chemotherapy without debulking (group C; n = 185). RESULTS: The median overall survival of all patients was 11.8 months. The median overall survival and 3-year survival rates were 28.0, 15.5, and 9.0 months and 42.8, 8.1, and 3.5% in groups A, B, and C, respectively. In group A, patients with peritoneal seeding, intra-abdominal distant lymph nodes, or ovarian or hepatic metastases underwent complete gross resection, and 12 (29%) were disease-free at the time of the last analysis (median follow-up duration, 29.1 months). On multivariate analysis, the adjusted hazard ratios for death were 0.27 (P < 0.001) and 0.64 (P = 0.024) for groups A and B, respectively, as compared to group C. CONCLUSIONS: Our study suggests survival benefits of debulking gastrectomy or gastrectomy plus metastasectomy in gastric cancer patients with distant metastases receiving systemic chemotherapy. Prolonged disease-free survival was observed after complete resection (gastrectomy plus metastasectomy) that may lead to cure in some patients. Well-designed prospective trials of the role of multidisciplinary approaches combining chemotherapy and surgery are needed to confirm the observations of our study.

Preparation and Practice of the Necessary Documents in Hospital for the "Act on Decision of Life-Sustaining Treatment for Patients at the End-of-Life".

PURPOSE: Six forms relating to decisions on life-sustaining treatment (LST) for patients at the end-of-life (EOL) in hospital are required by the "Act on Decision of LST for Patients at the EOL." We investigated the preparation and creation status of these documents from the database of the National Agency for Management of LST. MATERIALS AND METHODS: We analyzed the contents and details of each document necessary for decisions on LST, and the creation status of forms. We defined patients completing form 1 as "self-determined" of LST, and those whose family members had completed form 11/12 as "family decision" of LST. According to the determination subject, we compared the four items of LST on form 13 (the paper of implementation of LST) and the documentation time interval between forms. RESULTS: The six forms require information about the patient, doctor, specialized doctor, family members, institution, decision for LST, and intention to use hospice services. Of 44,381 who had completed at least one document, 36,693 patients had form 13. Among them, 11,531, 10,976, and 12,551 people completed forms 1, 11, and 12, respectively. The documentation time interval from forms 1, 11, or 12 to form 13 was 8.6±13.6 days, 1.0±9.5 days, and 1.5±9.7 days, respectively. CONCLUSION: The self-determination rate of LST was 31% and the mean time interval from self-determination to implementation of LST was 8.6 days. The creation of these forms still takes place when the patients are close to death.